|
|
|
| |
Brought to you by
|
|
| |
The latest Biotech News and Views |
|
|
|
Brought to you by
|
|
| |
|
|
| Download Acro's free eBook for an overview of current neuroscience research |
| Good morning! Before we jump in, a quick request: Biotech Snap launched in June and has grown faster than we ever expected. Now feels like the right moment to understand who's reading, what you value most, and how we can make it even more useful. We've put together a short reader survey, and your answers will help shape the next stage of Biotech Snap. It only takes a few minutes, and you'll have a chance to win a €250 (or $250) Amazon gift card.
Enjoy today's read!
- Joachim E. |
|
|
| SNAPSHOT |
| Arrowhead wins first FDA approval, igniting biotech rivalry with Ionis |
 |
| The FDA approved Arrowhead Pharmaceuticals' first drug, Redemplo, for treating familial chylomicronemia syndrome (FCS), marking the company's shift into commercial operations after over 20 years in development. |
| Why it matters: This approval positions Arrowhead as a direct competitor to Ionis Pharmaceuticals in the rare disease space and sets up a larger battle in the broader triglyceride treatment market, where both companies have high stakes. |
| Backstory: Arrowhead specializes in RNA interference (RNAi) therapies and has long trailed behind peers like Alnylam in getting a product to market. Redemplo is a quarterly injection that showed superior efficacy and safety in trials compared to Ionis' Tryngolza, the only other FDA-approved treatment for FCS. |
| Big picture: Arrowhead is pricing Redemplo at $60,000 per year, a tenth of Tryngolza's list price, in a strategic move to build long-term market share as it eyes larger indications like severe hypertriglyceridemia. Ionis' drug also carries a safety warning that Redemplo doesn't have. |
| Zoom in: Redemplo cut triglycerides by ~70% vs. 59% for Tryngolza in Phase 3 trials and could do a lot to help the ~6,500 people afflicted with FCS in the US alone. |
| What's next: Despite Arrowhead and Ionis being in an ongoing patent dispute, Redemplo will still be available by year's end. Future competition looms in the severe hypertriglyceridemia market, with Arrowhead expected to release trial results next year. |
|
|
| PRESENTED BY ACRO BIOSYSTEMS |
| Discover the Latest in Neuroscience Research |
 |
Explore cutting-edge insights into neuroscience with Acro Biosystems' comprehensive eBook. Get an overview of current research trends, methodologies, and breakthrough discoveries shaping the future of brain science.
Download your free copy today and stay ahead in neuroscience innovation. |
|
|
|
|
| SNIPPETS |
| What's happening in biotech today? |
| Bidding war: Alkermes has increased its offer to acquire Avadel Pharmaceuticals following a surprise bid from Lundbeck that Avadel initially deemed superior. The revised agreement values Avadel at up to $2.37 billion, including $21 per share in cash and a $1.50 per share contingent value right (CVR) tied to FDA approval of Avadel's narcolepsy drug Lumryz for idiopathic hypersomnia by 2028. While Lundbeck's earlier $2.4 billion offer included additional CVR payments, Avadel determined Alkermes' revised CVR terms were more achievable. Both companies' boards have approved the new deal, which is expected to close in Q1 2026, strengthening Alkermes' position in the sleep disorder market. |
|
| Bispecific deal: GSK has entered the emerging myeloid cell engager space by partnering with LTZ Therapeutics in a deal worth $50 million upfront, with additional milestone payments tied to the development of up to four preclinical cancer programs. Myeloid cell engagers, a novel class of bispecific antibodies targeting myeloid rather than T cells, aim to reshape the tumor microenvironment in both hematologic and solid tumors. The agreement grants GSK global rights to these assets, expanding its oncology pipeline following recent deals like its prostate cancer ADC pact with Syndivia. GSK joins peers including Pfizer, Novartis, Sanofi, and Eli Lilly in investing in this promising therapeutic modality. |
|
| Korean pact: Celltrion has signed a licensing agreement with fellow Korean biotech TriOar, securing the option to use TriOar's tumor-microenvironment-selective activation platform (TROCAD) for up to six therapeutic targets in a deal potentially worth over $350 million. The agreement includes an initial payment of $680,000, with up to $230.4 million in development milestones, $124.7 million in sales milestones, and tiered royalties of 2% to 3.5% if resulting drugs reach the market. This marks Celltrion's continued expansion beyond its biosimilar roots, following a recent $740 million deal for autoimmune assets from Kaigene, signaling a broader push into innovative biologics and antibody platforms. |
|
| Checks for AI: Profluent has raised $106 million in a funding round co-led by Altimeter Capital and Jeff Bezos' personal investment firm, bringing its total financing to $150 million to advance its AI-driven platform for programmable biology. The company specializes in using large-scale frontier AI models to design novel proteins, including genome editors, antibodies, and enzymes, with applications across therapeutics, agriculture, diagnostics, and biomanufacturing. Profluent has already made key breakthroughs, such as creating the first AI-designed CRISPR system and compiling the world's largest protein database. The funding will accelerate commercialization efforts and expand Profluent's platform capabilities, aiming to establish it as a leader in AI-powered protein design. |
|
| Trial tumble: Agios Pharmaceuticals' stock plunged by about 50% after its Phase III RISE UP trial of mitapivat (Pyrukynd) in sickle cell disease produced mixed results, achieving only one of two primary endpoints. While the trial met its hemoglobin response goal (40.6% of patients on mitapivat showed significant improvement versus 2.9% on placebo), it failed to show a statistically significant reduction in the annualized rate of sickle cell pain crises. Some secondary endpoints, such as improvements in hemoglobin concentration and markers of hemolysis, were met, while others, including fatigue scores, were not. Despite this, Agios plans to seek FDA approval for expanded use and will meet with the agency in early 2026. |
|
|
|
| SNAP AGAIN |
| Merck's HIV drug rivals Gilead's blockbuster in key trial |
 |
| Merck & Co.'s (MSD) HIV combo (doravirine + islatravir) matched Gilead's market-leading Biktarvy in a Phase 3 trial, hitting its main goal in treatment-naive patients and showing non-inferiority to Biktarvy at 48 weeks. |
| Why it matters: This success positions Merck to compete in the $5B+ HIV market, offering an alternative for patients seeking better tolerability, fewer drug interactions, and strategic options for long-term care. |
| Backstory: Integrase strand transfer inhibitors (INSTIs) like Gilead's bictegravir (Biktarvy) are the cornerstone of HIV treatment but carry risks of resistance and side effects. Merck has been developing islatravir as a new treatment backbone, particularly for patients switching regimens or those needing simpler, safer options. |
| Big picture: With potential FDA approval by April 2026 and EU filings ahead, Merck aims to challenge Gilead's dominance and grab hold of the 20% of HIV patients who change regimens yearly. The company even sees a chance to expand use beyond switching regimens to first-line treatment and weekly dosing regimens, which could reshape HIV therapy. |
|
|
|
|
| TOUR OPERATOR |
| Upcoming events |
| Brussels, 4-5 December 2025 – BIOVERSE Europe 2025 |
| London, 9-10 December 2025 – SynbiTECH |
| San Diego, 14-17 December 2025 – Antibody Engineering & Therapeutics |
| San Francisco, 10 January 2026 – Sachs Annual Oncology Innovation Forum |
| London, 19 January 2026 – Bioseed |
| Heidelberg, 4 February 2026 – Life, the biomedical convention |
| Dubai, 9-12 February 2026 – WHX Dubai |
| Göttingen, 19 February 2026 – Life Science Start-up Day |
| Amsterdam, 3-4 March 2026 – BioCapital |
| Barcelona, 10-12 March 2026 – Bioprocessing Summit Europe |
|
|
|
|
| Disclaimer: The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical or AZoNetwork. |
|
|
|
| |
|
|
|
|
|
|
|
